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P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) (17) Apply P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter PM: decision on the application for modification of an agreed PIP (137) Apply PM: decision on the application for modification of an agreed PIP filter RPM: decision refers to a refusal on the application for modification of an agreed PIP (1) Apply RPM: decision refers to a refusal on the application for modification of an agreed PIP filter RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) (1) Apply RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter W: decision granting a waiver in all age groups for all conditions or indications (32) Apply W: decision granting a waiver in all age groups for all conditions or indications filter

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Human medicine European public assessment report (EPAR): Nyvepria (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020, , , Revision: 2, Authorised, Last updated: 16/06/2021
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Human medicine European public assessment report (EPAR): Vimizim (updated)

recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014, , , Revision: 12, Authorised, Last updated: 16/06/2021
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Human medicine European public assessment report (EPAR): Riximyo (updated)

rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 15/06/2017, , , Revision: 5, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 13, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Rixathon (updated)

rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 15/06/2017, , , Revision: 4, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Aimovig (updated)

erenumab, Migraine Disorders
Date of authorisation: 26/07/2018, , Revision: 6, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021, , , Revision: 5, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Neparvis (updated)

sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016, , Revision: 12, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Skyrizi (updated)

Risankizumab, Psoriasis
Date of authorisation: 26/04/2019, , Revision: 5, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Zejula (updated)

Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017, , , Revision: 13, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Xerava (updated)

eravacycline, Infection, Bacterial Infections
Date of authorisation: 20/09/2018, , Revision: 2, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , , , Revision: 22, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Erelzi (updated)

etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Date of authorisation: 23/06/2017, , , Revision: 9, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Benlysta (updated)

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 26, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Zoely (updated)

Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, , Revision: 20, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Hulio (updated)

adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 17/09/2018, , , Revision: 6, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Talzenna (updated)

talazoparib, Breast Neoplasms
Date of authorisation: 20/06/2019, , Revision: 4, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Nepexto (updated)

etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020, , , Revision: 4, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Cresemba (updated)

isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015, , Revision: 11, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Inrebic (updated)

fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders, Primary Myelofibrosis
Date of authorisation: 08/02/2021, , , Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Ibrance (updated)

palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016, , Revision: 12, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Xeljanz (updated)

tofacitinib citrate, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,
Date of refusal: 25/04/2013, , , Revision: 18, Authorised, Last updated: 08/06/2021
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Human medicine European public assessment report (EPAR): Keytruda (updated)

Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015, , Revision: 35, Authorised, Last updated: 07/06/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)

Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014, , , , Revision: 10, Authorised, Last updated: 07/06/2021
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Human medicine European public assessment report (EPAR): Nexpovio (updated)

Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021, , , Authorised, Last updated: 07/06/2021